A certification of Suitability (CEP) holder, who wishes to possess a second CEP for the same Active Pharmaceutical Ingredient (API)/drug substance, can file a new application referred as a “Sister file”. It can be due to differences in API specification obtained with alternate process or to cover alternate grade of material. This is valid for all files except sterile, TSE or herbal applications.
A Sister CEP to the approved CEP filed with European Directorate for the Quality of Medicines and Health Care (EDQM), must be approved on a fast track basis compared to the approval timelines of original CEP applications. There are pre-defined conditions set by the EDQM that must be fulfilled in order to file the sister CEP. Hence, expertise is required to file the sister CEP with the EDQM for quick approvals.
Freyr has a very strong Regulatory team with mastery over compilation, review and submission of sister CEPs to EDQM in line with EDQM guidelines and requirements. With a strong footprint in handling sister CEPs, including submissions to EDQM for all types of APIs/drug substances, Freyr is proven to be a preferred Regulatory partner for API manufacturers.
- Regulatory strategy to finalise sister CEP submission acceptability for EDQM
- Designing the route of synthesis and API specifications for the same drug substance in line with EDQM requirements
- Regulatory assessment/gap analysis of source documents/data generated for sister CEP submission in line with current EDQM requirements/guidelines
- Compilation, review and submission of sister CEP in line with EDQM requirements for APIs
- Publishing of sister CEP in eCTD/NeeS/PDF as per EDQM specific requirements
- Evaluation of change controls for post-approval changes (PAC)
- Regulatory assessment of PAC and preparation of variation submission strategy
- Compilation, review and submission of variations (Type IA/Type IAIN/Type IB/Type II) to CEPs for PAC
- Compilation, review and submission of renewals for CEPs to maintain the lifecycle and validity of granted CEP
- Preparation of Regulatory strategy and response to health authority queries (RTQs) for quick approval of sister CEPs